(87 days)
Not Found
No Reference Device(s) K/DEN numbers were found in the text.
No
The device description focuses on automated pipetting and diluting using microprocessor control and robotic components, with no mention of AI or ML. The performance studies evaluate accuracy, precision, and carryover, which are standard metrics for automated laboratory equipment, not AI/ML performance.
No
The device is intended to prepare human whole blood samples for flow cytometric analysis in a laboratory setting (in-vitro diagnostic use) and does not directly treat or diagnose a medical condition in a patient.
Yes
The device is intended for in vitro diagnostic use, as stated in the "Intended Use / Indications for Use" section. It prepares human whole blood for flow cytometric analysis using specific previously cleared assays, which are used for diagnostic purposes.
No
The device description explicitly states it is a "microprocessor-controlled pipetting and diluting system" that "combines fluidic, optic, robotic, and electronic components" and includes physical parts like a "robotic pipetting module," "power supply," "central controller unit," "fluid pumps," and a "barcode reader." This indicates it is a hardware device with integrated software, not a software-only medical device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "For in vitro diagnostic use."
- Intended Use: The device is intended to prepare human whole blood for flow cytometric analysis using previously cleared assays. These assays are used to analyze components of blood, which is a biological sample taken from the human body.
- Device Description: The device description details how it processes biological samples (whole blood) with reagents and lysing solution for analysis.
- Accessory to IVD Systems: The device is used as an accessory to BD FACSCanto™ II and BD FACSCalibur™ flow cytometry systems, which are themselves IVD devices used for analyzing biological samples.
Therefore, based on the intended use, the type of sample processed, and the explicit statement, the BD FACS™ Sample Prep Assistant III is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The BD FACS™ Sample Prep Assistant III is intended to prepare human whole blood for flow cytometric analysis on BD FACSCanto™ II and BD FACSCalibur™ flow cytometry systems.
Pipetting blood, reagents, and lysing solution using the following previously cleared assays for flow cytometric analysis on BD FACSCanto II flow cytometry systems:
- BD Multitest 6-Color TBNK Reagent with or without BD Trucount Tubes .
- BD Multitest IMK Kit with or without BD Trucount Tubes .
- BD Multitest CD3 FITC/CD16+CD56 PE/CD45 PerCP/CD19 APC with . or without BD Trucount Tubes
- BD Multitest CD3 FITC/CD8 PE/CD45 PerCP/CD4 APC with or without . BD Trucount Tubes
Pipetting blood, reagents, and lysing solution using the following previously cleared assays for flow cytometric analysis on BD FACSCalibur flow cytometry systems:
- BD Multitest IMK Kit with or without BD Trucount Tubes .
- BD Multitest CD3 FITC/CD16+CD56 PE/CD45 PerCP/CD19 APC with . or without BD Trucount Tubes
- BD Multitest CD3 FITC/CD8 PE/CD45 PerCP/CD4 APC with or without . BD Trucount Tubes
- BD Tritest CD3/CD16+56/CD45 with or without BD Trucount Tubes .
- BD Tritest CD3/CD19/CD45 with or without BD Trucount Tubes .
- BD Tritest CD3/CD4/CD45 with or without BD Trucount Tubes .
- BD Tritest CD3/CD8/CD45 with or without Trucount Tubes .
- BD Tritest CD4/CD8/CD3 with BD Trucount Tubes .
For in vitro diagnostic use.
Product codes
PER
Device Description
The BD FACS™ Sample Prep Assistant III (SPA III) is a microprocessorcontrolled pipetting and diluting system which automatically prepares whole blood samples using the lyse / no-wash sample preparation method for flow cytometry. Used as an accessory to the BD FACSCalibur flow cytometer, the SPA III combines fluidic, optic, robotic, and electronic components to automatically prepare samples for acquisition and analysis.
The SPA III pierces the sample tube cap to withdraw sample, aliquots blood and reagent into daughter tubes, and mixes the sample according to preprogrammed or custom protocols. The device also adds lysing solution and automates cleaning procedures. The unit consists of an enclosure, one robotic pipetting module moving in the X/Y/Z axes, a power supply, a central controller unit, fluid pumps, and a barcode reader.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Children Children
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
| Study | Study Design | Results |
|---|---|---|
| Accuracy | Based on Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline, CLSI document EP9-A2 | The SPA III with the BD FACSCalibur system demonstrated equivalent performance in its ability to prepare human whole blood for flow cytometric analysis. |
| Precision | Based on Evaluation of Precision Performance of Clinical Chemistry Devices; Approved Guideline, CLSI document EP5-A2 | The SPA III demonstrated system precision within specification. |
| Carryover | Based on recommendations contained in Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA, December 4, 2001 | The SPA III demonstrated system carryover within specification. |
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.2750 Pipetting and diluting system for clinical use.
(a)
Identification. A pipetting and diluting system for clinical use is a device intended to provide an accurately measured volume of liquid at a specified temperature for use in certain test procedures. This generic type of device system includes serial, manual, automated, and semi-automated dilutors, pipettors, dispensers, and pipetting stations.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
0
-す
Section 5: 510(k) Summary
This summary of 510(k) safety and effectiveness is being submitted in accordance with the requirements of Safe Medical Devices Act of 1990 and 21 CFR 807.92.
The assigned 510(k) number is K131301
| 1.0 | Submitted By: | BD Biosciences
2350 Qume Drive
San Jose, CA 95131 USA |
|-----|-----------------|----------------------------------------------------------------------------------------------------------------|
| | Contact: | Kimberly Liedtke
Regulatory Affairs Specialist
Telephone: 408.954.4149
Email: Kimberly_Liedtke@BD.com |
| | Date Prepared: | August 1, 2013 |
| 2.0 | Device Name: | BD FACS™ Sample Prep Assistant III |
| | Classification: | Class II (21 CFR 864.5220 - Automated Differential
Cell Counter) |
3.0 Intended Use: The BD FACS™ Sample Prep Assistant III is intended to prepare human whole blood for flow cytometric analysis on BD FACSCanto™ II and BD FACSCalibur™ flow cytometry systems.
4.() Indications for Use:
1
Pipetting blood, reagents, and lysing solution using the following previously cleared assays for flow cytometric analysis on BD FACSCanto II flow cytometry systems:
- BD Multitest 6-Color TBNK Reagent with or without BD Trucount Tubes .
- BD Multitest IMK Kit with or without BD Trucount Tubes .
- BD Multitest CD3 FITC/CD16+CD56 PE/CD45 PerCP/CD19 APC with . or without BD Trucount Tubes
- BD Multitest CD3 FITC/CD8 PE/CD45 PerCP/CD4 APC with or without . BD Trucount Tubes
Pipetting blood, reagents, and lysing solution using the following previously cleared assays for flow cytometric analysis on BD FACSCalibur flow cytometry systems:
- BD Multitest IMK Kit with or without BD Trucount Tubes .
- BD Multitest CD3 FITC/CD16+CD56 PE/CD45 PerCP/CD19 APC with . or without BD Trucount Tubes
- BD Multitest CD3 FITC/CD8 PE/CD45 PerCP/CD4 APC with or without . BD Trucount Tubes
- BD Tritest CD3/CD16+56/CD45 with or without BD Trucount Tubes .
- BD Tritest CD3/CD19/CD45 with or without BD Trucount Tubes .
- BD Tritest CD3/CD4/CD45 with or without BD Trucount Tubes .
- BD Tritest CD3/CD8/CD45 with or without Trucount Tubes .
- BD Tritest CD4/CD8/CD3 with BD Trucount Tubes .
For in vitro diagnostic use.
Basic Description of the Device: 5.0
The BD FACS™ Sample Prep Assistant III (SPA III) is a microprocessorcontrolled pipetting and diluting system which automatically prepares whole blood samples using the lyse / no-wash sample preparation method for flow
2
cytometry. Used as an accessory to the BD FACSCalibur flow cytometer, the SPA III combines fluidic, optic, robotic, and electronic components to automatically prepare samples for acquisition and analysis.
The SPA III pierces the sample tube cap to withdraw sample, aliquots blood and reagent into daughter tubes, and mixes the sample according to preprogrammed or custom protocols. The device also adds lysing solution and automates cleaning procedures. The unit consists of an enclosure, one robotic pipetting module moving in the X/Y/Z axes, a power supply, a central controller unit, fluid pumps, and a barcode reader.
-
Predicate Device: 6.0
The BD FACSCalibur system, using the BD FACS™ Sample Prep Assistant III (SPA III) is substantially equivalent to the BD FACSCanto II system using the BD FACS™ Sample Prep Assistant III (SPA III). For both systems, the SPA III is used to prepare human whole blood for flow cytometric analysis. When used with the BD FACSCalibur system, the SPA III and manual pipetting are used for the same sample type and result in similar performance characteristics. -
Comparison to the Predicate: 7.0
Similarities and Differences:
| Characteristic | BD SPA III used with the
BD FACSCanto II system
(predicate) | BD SPA III used with the
BD FACSCanto II and
BD FACSCalibur systems
(modification) |
|----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The BD FACS™ Sample
Prep Assistant III is
intended to prepare human
whole blood for flow
cytometric analysis on BD
FACSCanto II flow
cytometry systems. | The BD FACS™ Sample
Prep Assistant III is
intended to prepare human
whole blood for flow
cytometric analysis on BD
FACSCanto II and BD
FACSCalibur flow
cytometry systems. |
| Sample Type | Whole blood | Same |
3
| Preparation
| Method | Automated | Same |
|---|---|---|
| Pipetting | ||
| Syringe | 1 mL sample/reagent | |
| syringe | ||
| 10 mL lyse syringe | Same | |
| Supported | ||
| primary | ||
| blood sample | ||
| tubes | Vacutainer | |
| Sarstedt | Same | |
| Probe Rinse | 3 pulses of approximately 1 | |
| second | Same | |
| Single- | ||
| dispense | ||
| excess drawn | ||
| reagent | ||
| (waste) | 4 µL | Same |
And Children Children
·
8.0 Summary of Performance Data
:
| Study | Study Design | Results |
|---|---|---|
| Accuracy | Based on Method | |
| Comparison and Bias | ||
| Estimation Using Patient | ||
| Samples; Approved | ||
| Guideline, CLSI document | ||
| EP9-A2 | The SPA III with the BD | |
| FACSCalibur system | ||
| demonstrated equivalent | ||
| performance in its ability to | ||
| prepare human whole blood | ||
| for flow cytometric | ||
| analysis. | ||
| Precision | Based on Evaluation of | |
| Precision Performance of | ||
| Clinical Chemistry Devices; | ||
| Approved Guideline, CLSI | ||
| document EP5-A2 | The SPA III demonstrated | |
| system precision within | ||
| specification. | ||
| Carryover | Based on recommendations | |
| contained in Class II | ||
| Special Controls Guidance | ||
| Document: Premarket | ||
| Notifications for Automated | ||
| Differential Cell Counters | ||
| for Immature or Abnormal | ||
| Blood Cells; Final | ||
| Guidance for Industry and | ||
| FDA, December 4, 2001 | The SPA III demonstrated | |
| system carryover within | ||
| specification. |
4
The BD FACS™ Sample Prep Assistant III with the BD FACSCalibur system demonstrates substantial equivalence to the predicate method.
:
5
Image /page/5/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three curved shapes that resemble a person embracing or supporting another, representing health and human services.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 2, 2013
BD BIOSCIENCES C/O MS. KIMBERLY LIEDTKE REGULATORY AFFAIRS SPECIALIST 2350 QUME DRIVE SAN JOSE, CA 95131
| Re: 510(k) Number: | K131301 |
|---|---|
| Trade/Device Name: | BD FACS™ Sample Prep Assistant III |
| Regulation Number: | 21 CFR 862.2750 |
| Regulation Name: | Pipetting and Diluting System for Clinical Use |
| Regulatory Class: | Class I |
| Product Code: | PER |
| Dated: | May 2, 2013 |
| Received: | May 7, 2013 |
Dear Ms. Liedtke:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
6
Page 2 - Ms. Kimberly Liedtke
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Maria M. Chan -S
Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
7
Indications for Use Statement
510(k) Number (if known): _K131301
Device Name: BD FACSTM Sample Prep Assistant III_
Intended Use:
The BD FACS™ Sample Prep Assistant III is intended to prepare human whole blood for flow cytometric analysis on BD FACSCanto™ II and BD FACSCalibur™ flow cytometry systems.
Indications for Use:
Pipetting blood, reagents, and lysing solution using the following previously cleared assays for flow cytometric analysis on BD FACSCanto™ II flow cytometry systems:
- BD Multitest 6-Color TBNK Reagent with or without BD Trucount Tubes .
- BD Multitest IMK Kit with or without BD Trucount Tubes .
- BD Multitest CD3 FITC/CD16+CD56 PE/CD45 PerCP/CD19 APC with or . without BD Trucount Tubes
- BD Multitest CD3 FITC/CD8 PE/CD45 PerCP/CD4 APC with or without BD . Trucount Tubes
Pipetting blood, reagents, and lysing solution using the following previously cleared assays for flow cytometric analysis on BD FACSCalibur™ flow cytometry systems:
- BD Multitest IMK Kit with or without BD Trucount Tubes .
- BD Multitest CD3 FITC/CD16+CD56 PE/CD45 PerCP/CD19 APC with or . without BD Trucount Tubes
- BD Multitest CD3 FITC/CD8 PE/CD45 PerCP/CD4 APC with or without BD . Trucount Tubes
- BD Tritest CD3/CD16+56/CD45 with or without BD Trucount Tubes .
- BD Tritest CD3/CD19/CD45 with or without BD Trucount Tubes .
- BD Tritest CD3/CD4/CD45 with or without BD Trucount Tubes .
- BD Tritest CD3/CD8/CD45 with or without Trucount Tubes .
- BD Tritest CD4/CD8/CD3 with BD Trucount Tubes .
For in vitro diagnostic use.
| Prescription Use _____________________________________________________________________________________________________________________________________________________________ | And/Or | Over the Counter Use _________________________________________________________________________________________________________________________________________________________ |
|---|---|---|
| (21 CFR Part 801 Subpart D) | (21 CFR Part 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Maria M. Chan -S
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